Active substance
Temazepam
- US FDA 24
- Health Canada 2
- US price lines 4
- NHS prices 3
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| RESTORIL | 15MG; 30MG; 7.5MG; 22.5MG | capsule · oral | SPECGX LLC | Prescription | 27 Feb 1981 |
| TEMAZEPAM | 15MG | capsule · oral | NOVEL LABS INC | Prescription | 21 Apr 1987 |
| TEMAZEPAM | 30MG; 7.5MG; 22.5MG | capsule · oral | NOVEL LABS INC | Prescription | 21 Apr 1987 |
| TEMAZEPAM | 30MG; 15MG | capsule · oral | ACTAVIS ELIZABETH | Prescription | 7 Aug 1987 |
| TEMAZEPAM | 15MG | capsule · oral | CHARTWELL RX | Prescription | 12 Jan 1988 |
| TEMAZEPAM | 30MG | capsule · oral | CHARTWELL RX | Prescription | 12 Jan 1988 |
| TEMAZEPAM | 7.5MG; 15MG; 22.5MG; 30MG | capsule · oral | PRINSTON INC | Prescription | 4 Jun 2015 |
| TEMAZEPAM | 7.5MG; 15MG; 22.5MG; 30MG | capsule · oral | AMNEAL PHARMS | Prescription | 23 May 2016 |
| TEMAZEPAM | 7.5MG; 15MG; 22.5MG; 30MG | capsule · oral | ALEMBIC | Prescription | 23 Nov 2018 |
| TEMAZEPAM | 7.5MG; 15MG; 22.5MG; 30MG | capsule · oral | ALKEM LABS LTD | Prescription | 24 Aug 2023 |
| TEMAZEPAM | 30MG; 7.5MG; 22.5MG; 15MG | capsule · oral | AUROBINDO PHARMA USA | Discontinued | 10 Jul 1986 |
| TEMAZEPAM | 15MG | capsule · oral | SUN PHARM INDUSTRIES | Discontinued | 10 Jul 1986 |
| TEMAZEPAM | 30MG; 22.5MG | capsule · oral | SUN PHARM INDUSTRIES | Discontinued | 10 Jul 1986 |
| TEMAZEPAM | 15MG | capsule · oral | DURAMED PHARMS BARR | Discontinued | 29 Sep 1988 |
| TEMAZEPAM | 30MG | capsule · oral | DURAMED PHARMS BARR | Discontinued | 29 Sep 1988 |
| TEMAZEPAM | 15MG | capsule · oral | WATSON LABS | Discontinued | 21 May 1993 |
| TEMAZEPAM | 30MG | capsule · oral | WATSON LABS | Discontinued | 21 May 1993 |
| TEMAZEPAM | 7.5MG | capsule · oral | SUN PHARM INDUSTRIES | Discontinued | 8 Sep 2009 |
| TEMAZEPAM | 15MG | capsule · oral | WATSON LABS | Discontinued | |
| TEMAZEPAM | 30MG | capsule · oral | WATSON LABS | Discontinued | |
| TEMAZEPAM | 15MG | capsule · oral | USL PHARMA | Discontinued | |
| TEMAZEPAM | 30MG | capsule · oral | USL PHARMA | Discontinued | |
| TEMAZ | 30MG | capsule · oral | QUANTUM PHARMICS | Discontinued | |
| TEMAZ | 15MG | capsule · oral | QUANTUM PHARMICS | Discontinued |
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | TEMAZEPAM 15 MG CAPSULE | $0.0767 | per EA | 23 Sep 2026 |
| US NADAC | TEMAZEPAM 22.5 MG CAPSULE | $1.54918 | per EA | 23 Sep 2026 |
| US NADAC | TEMAZEPAM 30 MG CAPSULE | $0.08929 | per EA | 23 Sep 2026 |
| US NADAC | TEMAZEPAM 7.5 MG CAPSULE | $0.83366 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Temazepam 10mg tablets | £26.47 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Temazepam 10mg/5ml oral solution sugar free | £150.80 | 300 ml | 1 Oct 2026 |
| NHS Drug Tariff | Temazepam 20mg tablets | £26.69 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No - US FDA 13 Jan 2023 RESTORIL — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.